Effect of Propolis Administration for Dysmenorrhea in Endometriosis Patient With Levonorgestrel Implant Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2023-07-11

Brief Summary

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The goal of this clinical trial is to investigate the effect of propolis administration on dysmenorrhea in endometriosis patient. the main questions it aims to answer are:

* Does the propolis administration reduce symptoms of dysmenorrhea in endometriosis?
* Does the propolis administration reduce the amount of oxidative stress biomarkers in endometriosis?
* Does the propolis administration reduce the amount of Inflammatory biomarkers in endometriosis?

Participants will be given an intervention in the form of propolis at a dose of 1 drop per 10 kilogram of body weight per administration, twice a day. there will be a control group that will be given an intervention in the form of a placebo containing 70% caramel alcohol dye solution.

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Detailed Description

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Conditions

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Endometriosis Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Endometriosis patients with menstrual pain who received LNG implant therapy were divided into two groups, each group consisted of 12 samples. The control group only received LNG, the treatment group received LNG with the addition of propolis. Propolis is given 2 times a day, namely in the morning before breakfast and at night before going to bed, with a dose of 1 drop /10 kg body weight (kgBW). Both groups were followed and reassessed after 1 month, 3 months both clinical and laboratory. Prior to receiving therapy, all subjects received education and signed informed consent for their willingness to participate in the study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

there will be a comparison group that will receive intervention in the same amount, preparation, and form, but only contain a placebo in the form of a 70% caramel alcohol dye solution. Investigator and participant will not know the contain of intervention that has given.

Randomization of participants was carried out based on the arrival of participants to the obstetrics and gynecology clinic at the Cipto Mangunkusumo Hospital by labeling A for the intervention group and B for the treatment group. then data collection is carried out according to research procedures

Study Groups

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Propolis

the subjects were asked to consume propolis 1 drop/10 kgbw/time given 2 times a day for 12 weeks. the dose will be calculated based on body weight by the certified nutritionist during the interview after the subject signs the informed consent form

Group Type ACTIVE_COMPARATOR

Propolis

Intervention Type DIETARY_SUPPLEMENT

intervention will use propolis extract (liquid-based) with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given to intervention group

Placebo

the subjects were asked to consume placebo (glucose-only contained) 1 drop/10 kgbw/time given 2 times a day for 12 weeks. the dose will be calculated based on body weight by the certified nutritionist during the interview after the subject signs the informed consent form

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group

Interventions

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Propolis

intervention will use propolis extract (liquid-based) with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given to intervention group

Intervention Type DIETARY_SUPPLEMENT

placebo

intervention will use placebo with 1 drop/10kgBW/times, 2 times in a day for 12 weeks. propolis will be given control group

Intervention Type OTHER

Other Intervention Names

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70% caramel alcohol dye solution

Eligibility Criteria

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Inclusion Criteria

* Women aged 20-49 years and already menstruating with complaints of menstrual pain referred to the obstetrics and gynecology polyclinic for LNG implant placement
* Willing to have LNG implant installed after receiving explanation about implants
* Not receiving hormonal treatment for endometriosis within the last 3 months
* Can receive drops (propolis) during the study

Exclusion Criteria

* Impaired liver function, degenerative diseases (DM, hypertension and cardiovascular disease), benign tumors, cancer
* Pregnancy and breastfeeding
* Hypersensitivity to levonogestrel
* Thromboembolic disease
* Experiencing bleeding for unknown reasons
* History of allergies to honey and its processed products
* Currently taking supplements/drugs that are not included in the standard management of endometriosis patients at RSCM
* Have consumed propolis before
* Received hormonal treatment within the last 3 months

Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes